CTIS2024-513808-34-00进行中（未招募）1 期
A randomized crossover clinical trial regarding the blockage of the mineralocorticoid receptor using Eplerenone on the evolution of arterial stiffness in kidney patients one year after transplant: EVATRAN (The effect of Eplerenone on the evolution of Vasculopathy in renal transplant patients). - CPRC2018/EVATRA
CHRU De Nancy0 个研究点目标入组 36 人开始时间: 2024年7月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female = 50 years of age, Patient who had a kidney transplant at least one year prior to inclusion, Patient treated with cyclosporine, Patient whose clinical-biological state has been stable for at least 3 months: no change in treatment with an impact on blood pressure (excluding immunosuppressive drug) for 3 months, no acute rejection diagnosed within 3 months, Patient with a glomerular filtration rate estimated according to the formula CKD-EPI =30mL/min/1.73m2, Patient with a peripheral PAS=110mmHg, irrespective of the presence or not of an antihypertensive therapy (including ACE inhibitors or sartan), Patient who signed informed consent, Patient affiliated with to beneficiary of a social security system
排除标准
- •Patient with documented kalemia = 5mmol/L in the last 15 days, Patient with known galactose intolerance, lactase Lapp deficiency, or glucose, galactose malabsorption syndrom, Contraindication to Sodium polystyrène sulfonate (potassium binder) administration : Intestinal obstructive disease and sorbitol laxative treatment, Patient participating in other interventional research, Female with a desire of pregnancy for the next 15 months, Female of childbearing age without effective contraception, Pregnant women, parturient women or nursing mothers, Adult person subject to a legal protection measure (guardianship, curatorship, judicial safeguard), Adults person who is unable to give consent and who is not subject to a legal protection measure, Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care pursuant to articles L. 3212-1 and L. 3213-1, Bicarbonate blood level <20mmol/L with or without documented supplementation in the last 15 days,, Patient undergoing mineralocorticoid receptor antagonism or with a formal indication to receive this treatment, Patients receiving potassium sparing diuretics, Patients treated with a combination of ACEi and ARBs (each of which is authorized separately);, Patient undergoing digoxin medication, Known hypersensitivity or allergy to eplerenone and its excipients, Patient with severe hepatic impairment (Child-Pugh Class C), Patient treated with potent CYP3A4 inhibitor (p.e. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycine, télithromycine et nefazodone)
研究者
相似试验
招募中
3 期
The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients. (EVATRAN)2024-513808-34-00CHRU De Nancy36
招募中
不适用
Clinical trial for evaluating validity of various acupuncture device typesKCT0001347Kyung Hee University Oriental Medical Center76
尚未招募
不适用
Clinical study to evaluate the efficacy and tolerability of the Meneguetti brush for self-collection of anal specimens to screen for anal cancer and sexually transmitted infectionsSexually Transmitted Diseases (STD)C04.588.274.476.411.307.790Anal CancerRBR-6nxst93Instituto Nacional de Infectologia Evandro Chagas - Fiocruz
尚未招募
4 期
The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE StudyThe crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE StudyJPRN-UMIN000040727Saitama Medical University Dept. of Endocrinology and Diabetology20
已完成
不适用
The randomized controlled crossover clinical trial of Red Koji (Red Mold Rice) in the serum lipid-improvement with dietary therapy for prevention of atherosclerosisDyslipidemiaJPRN-UMIN000013663Kanazawa University Graduate School of Medical Sciences16